Replies to post #632869 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

The bears only have two full trading days left until next week, wherein, the timeline is in full play.

Yup - next week is the week when FOMO should really pick up and shares are going to be held tight. I'd be shocked if they can drive it down after the 25th.

[ae kusterer]

flipper44:what's you timeline for the filing of the MAA? Thanks.A.E.K.

Re: reg2015 post# 632865

Wednesday, September 20, 2023 2:55:33 PM

Post#
632869
of 632874
The bears only have two full trading days left until next week, wherein, the timeline is in full play. It makes sense they are trying a smash down right now, however desperate it may be.



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MHRA Corporate Plan: What are the MHRA’s strategic objectives for medicines and medical devices 2023 to 2026?
Hill Dickinson
Hill Dickinson logo
European Union, United Kingdom September 15 2023
The Medicines and Healthcare products Regulatory Agency (the ‘MHRA’) has published its Corporate Plan for 2023 to 2026 in the regulation of medicines and medical devices.

The strategic priorities listed in the Corporate Plan for 2023 to 2026 are:

Maintain public trust through transparency and proactive communication
Enable healthcare access to new, safe and effective medical products
Deliver scientific and regulatory excellence through strategic partnerships
Become an agency where people flourish alongside responsive customer service
The MHRA has now also published a Business Plan for 2023 to 2024 specifically, which goes into further detail about actions and milestones proposed for the first year of the Corporate Plan.

A key focus for the next three years as set out in the Plan is developing the UK’s position as an attractive environment to develop medical devices and products, whilst driving legislative reform. Some of the key upcoming milestones which may be most relevant to healthcare providers include:

International focus

A key part of the three-year plan is developing the UK’s position in relation to medicines and medical devices following Brexit, in what the MHRA acknowledges is a highly competitive global market. This involves working both on a national level by strengthening work undertaken alongside UK healthcare providers (including the NHS), as well as on an international level, by continuing to develop strategic partnerships with international regulatory bodies and by driving international regulatory progress in key areas.

The priority regulatory pathways that the MHRA have indicated they will support are:

Vaccines and immunotherapies
Biotherapeutics, cells and gene therapies
Diagnostics and genomics
Data science
Artificial intelligence and software as a medical device
By 1 January 2024, the MHRA seeks to launch a new international recognition route for medicines utilising pre-existing approvals with the EU and with countries including Australia, Japan, and the United States.

Legislative reform

There are several areas of legislative reform that the MHRA is focused on to work towards its overall aim of strengthening the UK position in a global market.

Packaging and labelling: The Windsor Framework had been agreed between the EU and the UK to revise the Northern Ireland Protocol and enable the MHRA to grant UK-wide approvals for medicines with the same packaging and labelling to be used across the UK. The MHRA seeks to have implemented the Windsor Framework for a commencement date of 1 January 2025. As part of working toward this, they are aiming to have issued essential guidance on this by Q3 in Year 1 (by 31 December 2023), and to put legislation before Parliament in 2024.

Clinical trials regulatory framework: By the end of the first year of the plan (31 March 2024), the MHRA also aim to have prepared legislation to deliver reform of the UK clinical trials regulatory framework. As published earlier in the year (read more here), the MHRA seeks to overhaul existing clinical trial legislation, to streamline and simplify the application processes as far as possible and make the UK an attractive destination for clinical trials.

Medical devices: Lastly, the MHRA has stated that it seeks to drive forward the reform of medical devices regulation. This involves strengthening requirements for medical devices on the market and working on an international basis in order to clarify international recognition of devices approved in other jurisdictions.

It will be interesting to see how the MHRA works towards these milestones, and this should be welcome news for UK healthcare providers, as the MHRA makes progress in reforming and strengthening the UK’s position in relation to medical products, and as it transitions away from being a member of the European regulatory network.

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Wednesday, September 20, 2023 3:09:58 PM

Post#
632873
of 632877
MHRA Corporate Plan: What are the MHRA’s strategic objectives for medicines and medical devices 2023 to 2026?
European Union, United Kingdom September 15 2023

The priority regulatory pathways that the MHRA have indicated they will support are:
* Vaccines and immunotherapies
* Biotherapeutics, cells and gene therapies
* Diagnostics and genomics
* Data science
* Artificial intelligence and software as a medical device

https://www.lexology.com/library/detail.aspx?g=0d93c471-a053-44da-8ff0-cf818a56cfec

[DJPele]

Sept 28th will mark 30 days since the PR. Assuming they submit the MAA right on the 30-day mark (and not earlier), we may hear something by Oct 3rd (Tuesday Newsday).

Worst case scenario, they submit on the 45-day mark which lands on Friday, Oct 13th (spooky). In this event, we may hear something by Oct 17th (Tuesday Newsday).

My personal expectation for submission/acceptance news is Oct 26th, which takes into account the longest possible time frame for news, plus a week or two.

My gut feeling is we will hear something by the first week of October.